AMSCO 400 and AMSCO C Small Steam Sterilizers recall: Software Issue
AMSCO 400 and AMSCO C Small Steam Sterilizers
Why was AMSCO 400 and AMSCO C Small Steam Sterilizers recalled?
In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial #'s: 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, 030741306, 031491314, 032381302, 032341304, 033281222, 030621412, 030871412, 030871410, 031751401, 031771425, 031781412, 031781414, 031911436, R020141502, R020151501, R020191502, R020201501, R020261502, R020261504, R020271501, 030341514, R020471501, 030501540, 030651519, R021001503, R021051501
- Product
- AMSCO 400 and AMSCO C Small Steam Sterilizers
- Recalling firm
- Steris Corporation
- Quantity
- 32 units
- Distribution
- US nationwide distribution.
- Recall date
- November 11, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)